We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advancing Prevention of Pulmonary Fibrosis (APPLe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564183
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : August 22, 2022
Sponsor:
Collaborators:
Mayo Clinic
University of California, Los Angeles
University of Texas
University of Pennsylvania
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.

This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.


Condition or disease Intervention/treatment
IPF Pulmonary Fibrosis ILD Other: Sample collection Other: Questionnaires Radiation: High resolution CT scan of the chest Diagnostic Test: Pulmonary Function Test

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Full Cohort
Entire study population
 Other: Sample collection
Blood, Urine, Nail, Hair, Saliva, optional Stool

Other: Questionnaires
SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire

Radiation: High resolution CT scan of the chest
Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.

Diagnostic Test: Pulmonary Function Test
All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.
Sub-Cohort
Randomly selected sub-cohort from the larger group of all participants
 Other: Sample collection
Blood, Urine, Nail, Hair, Saliva, optional Stool

Other: Questionnaires
SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire

Radiation: High resolution CT scan of the chest
Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.

Diagnostic Test: Pulmonary Function Test
All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest [ Time Frame: Baseline ]
    All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.
Criteria

Inclusion Criteria:

  • Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
  • Age at least 40 years old and younger than 75 years old

Exclusion Criteria:

  • Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
  • Other genetic diseases associated with interstitial lung disease
  • Pregnant women
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564183


Contacts
Layout table for location contacts
Contact: Rachel Warren 303-724-8569 rachel.warren@cuanschutz.edu
Contact: Emily Culbertson 303-724-4025 emily.culbertson@cuanschutz.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Rachel Warren, BA    303-724-8569    rachel.warren@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Mayo Clinic
University of California, Los Angeles
University of Texas
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: David Schwartz, MD University of Colorado School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04564183    
Other Study ID Numbers: 20-1739
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases